MAUDE Adverse Event Report: CONMED CORPORATION 4.5MM POPLOK SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	CKP-4500
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer complaint that the "poplok broke into two pieces upon being deployed" is inconclusive.The device will not be returned for evaluation as it was discarded and no photographic evidence was provided.Therefore, the reported issue cannot be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment and found no abnormalities that would contribute to this issue.A two-year lot history review shows this is the only complaint for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 40 complaints, regarding 44 devices, for this device family and failure mode.During this same time frame 94,356 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.0005.The instructions for use (ifu) provides the user with information regarding proper care and use of this device.It is standard medical practice to inspect and/or test all medical equipment prior to use.Per the ifu, the user is also advised: to avoid lateral loading while inserting the poplok knotless suture anchor.Maintain proper alignment during insertion of the anchor and disengagement of the driver.Proper orientation and alignment of instruments is important during implantation of the poplok knotless suture anchor to minimize possible breakage of the anchor.Breakage of the poplok knotless suture anchor is possible if the bone punch is not inserted to the proper depth, the poplok knotless suture anchor is not properly aligned with the pilot hole, or the poplok knotless suture anchor inserter is used for prying.This product will continue to be monitored via returns and complaint system.
Event or Problem Description
The customer reported an issue with the 4.5mm poplok suture anchor, item # ckp-4500, lot # 976953 that occurred on (b)(6) 2019 during a rotator cuff repair involving a male patient.It was reported that approximately 60 minutes into the procedure (3/4 of the whole procedure) the poplok broke into two pieces upon being deployed.The anchor was removed from the shoulder and removed from the sutures it was attached to.All pieces were retrieved.It is noted that this was the first poplok being used in the procedure.Two more poploks were used after and worked as normal.It is indicated that there was no impact or injury to the patient and the procedure was successfully completed using another poplok with a reported 2- minute delay.It is indicated that the device was discarded post-op by the facility.This report is being raised on the basis of a device malfunction with potential of injury upon reoccurrence.

• Brand Name: 4.5MM POPLOK SUTURE ANCHOR
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd; largo FL 33773 4908
• MDR Report Key: 8711571
• Report Number: 1017294-2019-00070
• Device Sequence Number: 14118996
• Product Code: MBI
• UDI-Device Identifier: 10845854014103
• UDI-Public: (01)10845854014103(17)231119(30)1(10)976953
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K091549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/19/2023
• Device Catalogue Number: CKP-4500
• Device Lot Number: 976953
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1